What does the Drug Quality and Security Act (DQSA) enhance?

The Drug Quality and Security Act (DQSA) significantly enhances the detection of counterfeit and harmful drugs, which is crucial for ensuring the safety and integrity of the drug supply chain. This legislation was enacted in response to growing concerns about drug quality and security, particularly following incidents involving counterfeit medications that posed serious health risks to patients.

The DQSA introduced provisions that improve the FDA's oversight of drug compounding practices, establish a framework for the tracking and tracing of prescription drugs, and mandate the use of unique product identifiers. This enables better identification of drugs throughout the distribution process, making it easier to identify and remove counterfeit products from the market quickly. By enhancing the FDA's tools and authority, the DQSA works to combat the distribution of harmful drugs and ensure patient safety.

Additionally, the DQSA does not focus on aspects like monitoring drug pricing or improving consumer reporting of adverse effects, nor does it pertain specifically to the marketing of controlled substances. Its primary aim lies in strengthening the security of the pharmaceutical supply chain, making the detection of counterfeits and harmful substances more effective.